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Care and Handling Instructions
M6-C™ Artificial Cervical Disc Surgical Instruments
Manual Cleaning Process:
•
Prior to cleaning, disassemble any instrument capable of being disassembled.
•
Rinse the instruments under running tap water. Use a syringe to flush lumens and hard to reach areas. A
wire guide and/or pipe cleaner should be used to aid in cleaning lumens and other hard to reach areas.
Actuate any knobs, clamps, or joints while performing this process.
•
Prepare an enzymatic cleaning solution, such as Enzol®, per the manufacturer’s instructions.
•
Fully immerse the instruments in the prepared enzymatic cleaning solution and allow them to soak for a
minimum of one minute.
•
After the soak, use a soft bristle brush to thoroughly clean any crevices or other difficult to clean areas of
the instruments. Flush lumens and small spaces with a syringe. A wire guide and/or pipe cleaner should be
used to aid in cleaning lumens and other hard to reach areas. Actuate any knobs, clamps, or joints while
performing this process.
•
Remove the instruments from the enzymatic cleaning solution and rinse them with reverse osmosis or de-
ionized (RO/DI) water for a minimum of one minute. Use a syringe to flush lumens and hard to reach areas.
Actuate any knobs clamps or joints while performing this process.
•
Prepare a neutral detergent, such as ValSure® Neutral Detergent, according to the manufacturer’s
recommendations using warm tap water in an ultrasonic bath.
•
Fully immerse the instruments into the sonication bath and sonicate for two minutes.
•
Remove the instruments from the neutral detergent solution and rinse them with RO/DI water for a
minimum of one minute. Use a syringe to flush lumens and hard to reach areas. Actuate any knobs, clamps,
or joints while performing this process.
•
Dry the instruments using a clean, lint-free cloth to avoid damage to the surface. Pressurized air (20psi) may
be used to assist in drying.
•
Visually inspect the surgical instruments for cleanliness. If instruments are not visually clean, then repeat the
entire cleaning process.
Automated Cleaning Process:
•
Prior to cleaning, disassemble any instrument capable of being disassembled.
•
Rinse the instruments under running tap water. Use a syringe to flush lumens and hard to reach areas. A
wire guide and/or pipe cleaner should be used to aid in cleaning lumens and other hard to reach areas.
Actuate any knobs, clamps, or joints while performing this process.
•
Prepare an enzymatic cleaning solution, such as Enzol®, per the manufacturer’s instructions.
•
Fully immerse the instruments in the prepared enzymatic cleaning solution and allow them to soak for a
minimum of one minute.
•
After the soak, use a soft bristle brush to thoroughly clean any crevices or other difficult to clean areas of
the instruments. Flush lumens and small spaces with a syringe. A wire guide and/or pipe cleaner should be
used to aid in cleaning lumens and other hard to reach areas. Actuate any knobs, clamps, or joints while
performing this process.
•
Remove the instruments from the enzymatic cleaning solution and rinse them with reverse osmosis or de-
ionized (RO/DI) water for a minimum of one minute. Flush lumens and small spaces with a syringe. Actuate
any knobs, clamps, or joints while performing this process.
•
Place the instruments into the washer for processing.
•
Run the validated cycle parameters below.